#255 Duane Mancini — Project MedTech

Duane Mancini [00:00:00]:
It's like, you know, there's, there's so many of those stories where you don't know the impact you're having on people or connections or their journey. And yeah, I thought that was always really shocking and cool as well. So I just think those have been big learning experiences for me. For sure. Every episode I learned something new about someone's journey, something cool going on or a different way to think about something.

Jeffrey Stern [00:00:24]:
Welcome to the Lay of the Land podcast where we are exploring what people are building in Cleveland and throughout Northeast Ohio. I am your host Jeffrey Stern and today I had the real pleasure of speaking with Duane Mancini, Founder and CEO of Project MedTech, a Cleveland based platform helping medical technology companies move from promising invention to real patient impact. What began as a podcast has evolved into a broader ecosystem of consulting events, education, investor connectivity and community building for medtech founders navigating the difficult path from idea to market. In our conversation, Duane and I explore his path from science and research into entrepreneurship and how Project MedTech grew from a curiosity driven podcast into this larger platform and what founders often underestimate about building in medtech. We talk about regulatory strategy, reimbursement, clinical validation, fundraising, the importance of team and why Ohio has a unique opportunity to become a more important node in healthcare innovation globally. Duane is thoughtful, mission driven and deeply committed to helping more life changing technologies reach patients. So please enjoy this insightful conversation with Duane Mancini. Lay of the Land is brought to you and is proudly sponsored by Serity Partners.

Jeffrey Stern [00:01:38]:
As a wealth management firm, Serity Partners shares Lay of the Land's same dedication to serving local business owners and the Serity Partners Cleveland team understands the challenges that entrepreneurs and founders face here in Cleveland, Northeast Ohio and beyond. Wealth comes with complexity and increased demands on time and resources, it is easy to become overwhelmed. Serity Partners clients benefit from a unified team of local specialists who coordinate across both business and personal needs. With Serity Partners commitment to transparency in putting clients needs first, complexity can become clarity. To learn more please visit seritypartners.com or call 216-464-6266 today. Serity Partners proud to be recognized as one of the top financial advisory firms in the country. I've always admired authentic community first projects where the storytelling becomes the wedge and the platform to build trust to learn. As we were just talking about, to kind of understand an ecosystem and create a foundation for something bigger, something more impactful and something so I've been looking forward to having you on for a while now because I feel you've built this and continue to build upon it, like, really elegantly with Project MedTech in ways that I've admired from afar, because in a lot of ways, that is what I'm striving to do, you know, as well.

Jeffrey Stern [00:03:07]:
And so just looking forward to learning how you came to this kind of work, how it's evolved into what it is today. In a lot of places we could start. But just given some of the parallels in the spirit of what we're doing, I really am curious, like, when you started Project MedTech, what did you think you were building at the time and how. Obviously, it's evolved in a lot of ways, but what was the problem that you saw? What was the curiosity you had?

Duane Mancini [00:03:38]:
Yeah, yeah. I think when I had taken my first business development role at namsa and it was talking to a lot of startup companies, it was very apparent that we weren't. We just weren't solving for the actual crux of the issue that these startup companies in life sciences were dealing with. And then I think also the other part of it, too, was I was getting to spend time in other areas that weren't Boston, New York, or San Francisco and learning about all this really cool innovation out there, but they weren't getting the headline of a $20 million seed round or a $10 million seed round. And so part of it was, hey, there's other things going on. I wonder if I can create a platform that talked about those things and talked about these other areas, these other startup companies where innovation's happening. And then the other piece of it, too, was these. These companies, especially in life sciences, you know, you have to have local community backing.

Duane Mancini [00:04:52]:
And then there's this next layer of like, well, how do you expand beyond that? And, you know, if we could use the podcast and then eventually our event section to kind of build this network and then give it away to the companies we work with. Well, then, you know, there could be something special there. You know, it's like, if we can maintain this. This network and make it really easy for great teams with great products to get to that next layer beyond their local ecosystem, you know, that would create a lot less friction for these startup companies. And I thought the podcast was a great way to start doing that.

Jeffrey Stern [00:05:33]:
Start doing it? Yeah, because it. Yeah, because it's interesting if you were to just describe Project MedTech as a podcast or as an events platform or as a consulting firm, it's missing, like, the. The aggregate of what it is. So, like, how do you. How do you articulate what is Project Medtech.

Duane Mancini [00:05:54]:
Yeah, we, we, we talk about it as we're networkers, educators, educators and consultants. I mean that's, that's the core of what we do. And we do that in a few different vehicles. Right. Our, our vehicles are, you know, hey, we're going to have this podcast where yes, we're educating. And it seems at the surface, you know, that's, that's all that really is. But it's also that we're networking and, and then on the event side it's the same thing. We're educating at our events, but we're also networking.

Duane Mancini [00:06:25]:
And on the consulting side of the business, what we're enabling entrepreneurs to do is to get the resources they need in a really cost effective manner. Right. Life sciences, life science companies are so far away from revenue at the start of their company. And so, and the team that they're going to have as a commercial stage company versus a pre commercial company is so different. And so if we can give them the fractional resources they need at the right time, all under one roof so that you do get the value of having a finance, regulatory, quality, reimbursement, commercial, all looking at the opportunity from a very early stage. But you can move those people in and out as you need it. It makes those companies really capital efficient before they have to raise large commercial rounds. And so a lot of what we do is just, we are here for founders and that's a big piece of our passion here, is that we want to support founders and give founders truly what they need, which is they need the resources that we provide on consulting, they need the network that we can help build and foster and maintain for them.

Duane Mancini [00:07:41]:
And they need the educational resources so that they understand where the pitfalls lie. And so yeah, it's been a really easy mission and vision for us. When you put that, put that at the center of it.

Jeffrey Stern [00:07:53]:
Absolutely.

Duane Mancini [00:07:54]:
Yeah.

Jeffrey Stern [00:07:54]:
Maybe just to take a step back and kind of ground this in your story, what, when you reflect on it, do you feel kind of first set you on this path that would pull you into the world of life sciences and med tech? Where does that interest stem from?

Duane Mancini [00:08:12]:
Yeah, I've always been in sciences. When I was a kid growing up, especially in high school, I definitely gravitated towards the sciences. I thought I wanted, wanted to be a pharmacist originally. And then when I went to the University of Toledo, I realized that I was really intrigued by research, like new groundbreaking products. My first research product was working in the breast cancer space. And I can remember going to the Susan G Komen Race for the Cure in Toledo and seeing they, they, they were. They actually funded some of the research at the University of Toledo. And so I remember going there and just seeing like, being just very inspired by all the people there, all the survivors, but also the other people doing research there, you know, and this Race for the Cure.

Duane Mancini [00:09:05]:
And from there I had this, you know, thing that I was like, I'm going to go work for the Cleveland Clinic one day. You know, like, that was it. I'm going to go to Cleveland. I'm going to work at the Cleveland Clinic. I'm going to be in research there. And yeah, I mean, that just, that frankly started the whole spiral of like, I'm going to be in new innovative products. And then it was very easy to get almost addicted to like the. I got to see things years before they hit the market.

Duane Mancini [00:09:33]:
And I got to work with the coolest new ideas. Most will never work. And, and, and, but the, but the, but the 10 to 20% that get through and, and actually get to the clinic and get to patients, it was just really cool to know you had a hand in it. So that was the earliest I can remember. Like, I knew I wanted to be in health and life sciences, but I think like any high school kid, I was like, oh, I'll be a pharmacist, you know, or a doctor or a nurse or whatever it is. And. But then getting into college and getting into research, it just was like, I thought it was the coolest thing in the world, which most people don't.

Jeffrey Stern [00:10:10]:
Right, right. When did you feel the first kind of entrepreneurial inclination from all that?

Duane Mancini [00:10:18]:
That was for sure when I got into sales. So. So most of the roles I had before that were technical in nature. You know, I got to spend time as a chemist, but then I got to spend time doing toxicology work. I got to spend time doing. How do you get a product through the fda. I got to spend time in. In how do you get a medical device paid for? And reimbursement and, and, you know, clinical trial design and execution and these really technical roles.

Duane Mancini [00:10:45]:
And then I got asked to take a sales role. And I was. I thought I was really nervous to take that role. Cause I was a scientist. But then I just became really enthralled with the idea of business development and sales and what that was like and the process and solving people's problems and having conversations with folks and it was really awesome. And then I think that is at fault, though, for the entrepreneurial bug too, because, you know, I kind of realized that, hey, I had this unique skill set and why not me? Why can't I go do this? You know, what's preventing me from solving this problem that I see? And yeah, that, that's, that is a hundred percent where it came from is that I saw this problem, I saw a unique ability to solve it. And yeah, maybe I was, I had too much confidence that I thought I could do it.

Jeffrey Stern [00:11:36]:
Yeah, you need a little bit of the, the naive belief in yourself.

Duane Mancini [00:11:42]:
That's right. Yeah, yeah, yeah. And a support system though, that challenges you on it. Because I do think that, you know, the idea started in 2020, right. And I didn't go full time into Project Medtech until the end of 21, beginning of 22. And I think that, you know, because I was able to do it, I was forced to do it. I mean there was, you know, in, in 2020, from the time I had the idea for Project MedTech Covid had started, my, my wife had told me she was pregnant, you know, with our, our first child. And I was thinking about leaving a job.

Duane Mancini [00:12:20]:
Right. And so I ended up transitioning jobs. So you know, financially I had that security because I was still working and doing Project Medtech on the weekends and at nights. But, but I think that, you know, to have a, a network and advisors around you that challenge you on when it might be the right time to actually do it. And have you thought about this and have you thought about that and what happens if this happens? I think is, is really important and actually gave me more confidence to say, hey, I am answering all these questions. It's ready, it's go time. You know, let's, let's make the lead.

Jeffrey Stern [00:12:55]:
So to help orient us around like the problem that you were solving and the opportunity that you saw, I think it would be helpful to understand because you've had this, this I think pretty unique vantage point end to end. What does it take to, to bring a, an invention through to commercialization? You mentioned some of it. The biological safety work, the regulatory work, the reimbursement, the trial design, the clinical strategy, the go to market, like not the normal software cpg, you know, kind of business. So like what does it actually take soup to nuts to bring an invention into the world? And what did you come to understand about what the aspirational first time founder will likely only learn the hard way about what that actually takes and how you could help them?

Duane Mancini [00:13:49]:
Yeah, yeah. I think one of the things to start was like there was this perception that you needed all the capital and all the capital sat on the coast. And I'm sure that is accurate to some extent. Right? I mean there are, there's more VC capital on the coast. I understand that. I think the, the initial thing that I saw that I found really interesting is like if you just named, if you asked people to name five major hospital systems, when you think of like a top tier hospital institution, I think a few of them would be in the Midwest. Right. But you don't hear about a lot of innovation.

Duane Mancini [00:14:27]:
Like people would for sure name the Cleveland Clinic. You're probably going to name Mayo Clinic. And there's others that could be on the list as well. I'm not trying to exclude anyone, but those ones, if you ask just a normal person on the streets would name those institutions. And so the whole idea was, hey, there's, there's probably a better way to do this, but I don't think people know all the different voices that need to be in the room when you're going through this. And also there's a more capital efficient way to go about doing this. Like, how do you continue to de risk your company and product before you start to lose control of your company? Because you're going to have to raise capital, it's going to take money to get to market and, and as you raise more capital, you lose more and more control of your company. And so can you do this in a more cost effective way? I think a lot of early stage entrepreneurs are going to probably have the perception that they, it's all about their product.

Duane Mancini [00:15:30]:
And we've done 260some episodes of our podcast. We've talked to a number of investors. None of them would put product over team. Every single person we've talked to puts team over product. And so you need a strong team. Well, how do you get a strong team when you're trying to be super cost effective with this? And so it's like if we can put a lot of these resources in place where, you know, you don't have to worry about finance, you don't have to worry about regulatory, you don't have to worry about clinical or commercial or reimbursement. But you have these people around you at the table. You know, you, you can be, you can get it de risked enough and get it farther along than you think.

Duane Mancini [00:16:18]:
And I think that also fits a lot with like the Midwest scrappiness. Our clients are all over the, the, the globe. But that was, that was, we're Midwesterners though. Me and my two other co founders were, were Midwest guys and So I think there's that scrappiness to it. And I thought that, you know, this could be a really interesting thing to partner with some of these other innovations that are spinning out all over the place in areas you might not think of and kind of pull them along with this Midwest scrappiness to continue to de, risk the product more.

Jeffrey Stern [00:16:51]:
Pull on the thread of team. How would you apply that to your, to yourself? You know, how did, how did, how did the founding team come together? What's the story there?

Duane Mancini [00:17:01]:
Yeah, yeah. So Rich Mazzola is, is one of the co founders and Aaron Tenhusen is, is another one of the co founders. I think for me, I had the, the big vision. I always joke about this. Like if, if the three of us were standing at the bottom of a staircase, I looked directly to the top and, and I, I, I look at the top and go, oh yeah, we can get there, no problem. Aaron looks three steps ahead and goes, hey, that's cool, Dwayne, but we gotta get here first. And Rich looks at the very next step like that's, that is our skill set and it balances us as it balances us out. And I think some of that early stage advice that I would give an entrepreneur is, hey, figure out what your weaknesses are and compliment those.

Duane Mancini [00:17:44]:
And for me, I have, I'm definitely probably more on the head in the, in the clouds type of individual. You know, I see the big picture of where we need to go, but I need help getting there and focusing on those steps and figuring out what those logical steps are along the way. And Aaron and Rich balance those out perfectly. We also balance each other out from. I definitely have more of a commercial background, Aaron has more of an operations background. And Rich is a fractional, been a fractional CFO for a number of years. And so it kind of was the Project MedTech model to find, to found Project MedTech. Right.

Duane Mancini [00:18:26]:
I never had to worry about finances. I was able to offload that operationally. We were able to, you know, Aaron took that and so it let us really play to our strengths and how we all met's a whole nother story. Rich was a plus one at my wedding originally, actually. But we got to meet each other and talk more and built a good relationship. And Aaron and I, oddly enough, played volleyball together. And he was not even in life sciences. He was in automotive.

Duane Mancini [00:18:56]:
He said, you know, I really, I, he wanted to just, he just said, I kind of want to get into life sciences. It seems really interesting. I want to change. And at that time Project MedTech had already been formulated and I was like, you know, I, I kind of want to make a run at this. Now let's start getting things in place. Would you be interested in this? And pitched him on the idea and he came on board.

Jeffrey Stern [00:19:20]:
Lave the Land is brought to you and is proudly sponsored by Roundstone Insurance. Headquartered in Rocky River, Ohio. Roundstone shares Lay of the Land's same passion for bold ideas and lasting impact from our community's entrepreneurs, innovators and leaders. Since 2005, Roundstone has pioneered a self funded captive health insurance model that delivers robust savings for small and medium sized businesses. They are part of the solution to rising healthcare costs, helping employers offer affordable, high quality care while driving job creation and economic growth throughout Northeast Ohio. Like many of the voices featured on Lay of the Land, including Roundstone's founder and CEO Mike Schroeder, Roundstone believes entrepreneurship, innovation and community to be the cornerstones of progress. To learn more about how Roundstone is transforming employee health benefits by empowering employers to save thousands in per employee per year healthcare costs, please visit roundstoneinsurance.com Roundstone Insurance built for entrepreneurs, backed by innovation, committed to Cleveland how would you describe the chapters of Project MedTech and how it's evolved and just kind of where you see it today? If you're like looking up at the stairs, what you see ahead of you, just what's behind you, how many steps have you climbed?

Duane Mancini [00:20:37]:
Yeah, that's a good question. The first chapter was the kitchen table chapter. I actually just sent Aaron and Rich a picture of it the other day. You know, it's my, my now five year old daughter in like a little high chair, you know, so many months old sitting on the table while me and Aaron are talking about, you know, where we want to go. It's funny, we laugh about it frequently, but we used a thing called a Miro board, which is honestly just a virtual whiteboard. But we put a lot of things up there and said, hey, this is what we want it to look like at scale. How do we, how do we get there? What do we want it to do? And some things were green, some things red, but if we turn something red, we always put a reason why the, the whiteboard looks like we thought it would look like. It's funny how little it changed, maybe details of a change, but big picture wise, you know, we're, we're doing what we wanted to do.

Duane Mancini [00:21:34]:
We, we always had aspirations of, of having the consulting company, we wanted to have companies that we took equity in and have Like a little venture studio play. And we, we do have those. We want events company to be an independent thing. That was very important for us that it. It. We were never, we were never doing it just to drive consulting business, but we were doing it. We wanted to maintain that network, bring people together. All tide.

Duane Mancini [00:22:06]:
A high tide Raids rises All boats. Same thing with the, the podcast. I mean we're, we're doing all those things. We've, we've. We're really working on tacking on this, this venture arm so we can actually make some more investments as well. And so, you know, I think it looks very similar to what we had planned. And I think at this point from a expansion y perspective, we're, we're as far as we want to go now. Like there's not like anything new on the horizon.

Duane Mancini [00:22:38]:
We're now, we're in depth mode. How do we build more depth in all of these areas? And so I don't know where we're at in the staircase because I don't know where Aaron would define that, but from a. If, if it was. If the staircase was where we're at from what we're going to be. We're, we're at the top almost now. Now we got to climb the next staircase, which is building organizational depth in all of these areas, which there. We're, we're, we're starting to build that team. We're feeling really good about the team we have in place.

Duane Mancini [00:23:12]:
And so we're definitely starting that, that, the climbing of that staircase as well.

Jeffrey Stern [00:23:16]:
So there's a lot of, A lot of pillars in the business we could, we could talk about. But I really more just because I again, I think there's a lot of parallels in the journeys we've been on here and the evolution of the platform. But what sticks out to you when you reflect on 250 plus conversations with folks that are traversing this very difficult path of what does it look like to take an invention to market?

Duane Mancini [00:23:43]:
Yeah.

Jeffrey Stern [00:23:43]:
What have you learned? You know, a lot of the, the impetus that got us into this in the first place was these, these podcasts are the best way to learn from the best of what other people have already figured out. What.

Duane Mancini [00:23:54]:
Yeah.

Jeffrey Stern [00:23:55]:
What sticks with you?

Duane Mancini [00:23:56]:
Yeah, totally. I mean, to your point, Jeffrey, like, it's like, I think we get the question all the time because it is an independent, like, revenue stream for us. People are like, oh, if you didn't have a lot of listeners, would you still do it? And it's like, of course, you know, like what A nice. What a great way to bond with someone and talk with someone and, and what a way to learn. Like, selfishly for me, yeah, I've learned. I just learned so much from this experience. And there's specific episodes that stick out. There is really emotional moments that stick out.

Duane Mancini [00:24:29]:
I just had one that. It's not released just yet. It's coming out in the coming weeks. But I, it's like we've done 260 episodes. You, you know, you've done over 250 and you can think back to specific moments that shock you and to constantly be surprised. Like, people always ask that, like, are you surprised anymore? I just had one where the first 15 minutes I hadn't been that emotionally wrapped up into a podcast since we've been doing it. Like, she shared a deeply personal journey story in front of our audience. And it was so emotional, sad.

Duane Mancini [00:25:10]:
Like just the, all the feelings that it was the first time I felt silly asking more questions, you know, like, it just, I don't know, like you have moments like that that just shock you all the time. There's, there's pieces of advice that I do this frequently. I have a notes section on where I'm an Apple user, so my phone, my iPad, my laptop, and I call it my master's in business because I didn't get an mba, but. But I'll put little pieces of advice that I pick up from people's episodes. Or I'm like, wow, that's super powerful. I got to add that in. And I just find myself, you know, it's like, it feels like every 10 to 15 episodes, that list just gets longer and longer.

Jeffrey Stern [00:25:54]:
Yeah, it's an ever growing list.

Duane Mancini [00:25:56]:
Yeah. But that's, that's selfishly for me, that's really cool. That keeps you going. That's a big learning experience. The other piece is what, what other. Another big learning experience was just. It's surprising how many different people listen to the podcast. You know, for us, like, obviously you gotta be really passionate about MedTech to listen to a podcast called Project MedTech.

Duane Mancini [00:26:21]:
But people all over the world, like, we would get outreach and they'd be like, hey, Dwayne, I've been listening to your episode for your podcast for four years. My, my. I finally licensed this technology out. I'd like to talk to you about some consulting work. Like that would always me is that someone was listening for that long. Or we would get people who reached out and say, hey, I did the podcast with you. And a person from this company reached out to us. And now we have a partnership.

Duane Mancini [00:26:48]:
It's like, you know, there's, there's so many of those stories where you don't know the impact you're having on people or connections or their journey. And yeah, that, I thought that was, you know, always really shocking and cool as well. So. Yeah, I, I just think those, those have been big learning experiences for me for sure. And then it's like every episode I learned something new about someone's journey, something cool going on or a different way to think about something.

Jeffrey Stern [00:27:14]:
Yeah, it certainly resonates. I mean all the, the downstream implications that you, I mean sometimes you don't hear about that for two years, three years, you know, after it, it's happened and it's, it's, it's always, it's always pretty powerful and amazing to hear. Yeah.

Duane Mancini [00:27:33]:
And like, I mean like, like for you too, it's, you know, you, you think about, even think about the in person events, you know, you've, you've had and hosted. I, I just missed your most recent one, but you had one a few years ago at Playhouse Square and you know, you think back to like, stuff like that. So think about all the people who connected at that event and potentially walked away with something and where that's gone. And I think for me too, I've always talked about this in the podcast. I think that if you do things unselfishly, things will come back to you. Like, I'm a big believer in that as well. And, and, and it might not happen on the same time frame that you would want. And if you look at it super analytically and it's like, well, if I do this, then I need this result, you know, I don't know.

Duane Mancini [00:28:20]:
I think if you have that man's mindset, then yeah, you, you'll hate doing podcasts or doing events or anything like this. It's a long game, you know, and it's hard somet point to specific results, but if you put good out there, good will come back.

Jeffrey Stern [00:28:34]:
That also resonates quite a lot. So you had talked about de risking and I think it's because of how unique the, the actual business process is relative again to, I don't know, enterprise software, where the market will tell you very quickly whether or not something is working. The feedback loops are really tight and quick. What does de risking actually look like and what have you come to understand about what people can do to actually de risk and maybe try and shorten the feedback loop relative to a lot of other markets where reality is just going to Tell you real quick.

Duane Mancini [00:29:17]:
Yeah, right. I think the biggest thing in life sciences medtech is clinical data. Like this is, this is absolutely the, the, the top of the, the top of the food chain. You know it. I think some people coming into the industry is like when you get FDA clearance, you know that's a big deal. And it still is a big deal, but it's not. The FDA doesn't purchase your product. The FDA gives you a license to say, hey, you could sell your product, right.

Duane Mancini [00:29:46]:
You can, you can be in the clinic. Clinical data is 100, the biggest de risking platform that you can work towards as an early stage company. And, and I think that's part of when I talk about a Midwest advantage. That is the advantage of the Midwest. Right. Covid changed things from an investment side. Yes. I think there was a piece of data that someone shared in an event after Covid and it was before COVID your initial seed investors were a hundred miles away from you.

Duane Mancini [00:30:21]:
After Covid it was 600 miles. And we certainly see that. We work with companies all over the globe. People are investing in companies out of Florida, from Michigan, I mean all over the place. Like that's just one example. But I think for a Midwest advantage, what better way to get good clinical feedback from people? You're going to have your early adopters, right? The first hospital you can convince to say hey let's, let's try this on 10 patients or let's try this on one floor or one site. But how do you go get feedback from people who maybe aren't early adopters who are going to push a little bit more? And there's with, within a, within the US healthcare system there's a lot of different types of hospitals. And in the Midwest you can get to a lot of different types of hospitals really quickly.

Duane Mancini [00:31:11]:
Like if you just think about Cleveland and the patient population that Cleveland, you have three very different hospitals. Metro Cleveland Clinic, University Hospital, within a two hour drive you have two hospital systems in UPMC and Allegheny that are provider but payer healthcare systems. Right. That's a pretty cool advantage. Now you can see, hey, maybe this works really well at Cleveland Clinic University Hospitals. How does it work in UPMC or Allegheny's health system? Also in the Midwest you have very rural populations. So how do you take this to a rural hospital system and figure out does this fit in well at this hospital system? And so I think when you think about this, it's achieving clinical data is the highest bar you can clear. And it takes a lot of time to do that because you want to get there, you want to live on site, you want to see how it's being used, you want to see what the problems are.

Duane Mancini [00:32:10]:
It's a complicated system. It's also a very rewarding system. Right. We, you know, we, we've seen some big announcements in the Cleveland area just in the last couple weeks with some, some big acquisitions. Right. And so, and, and those are really cool. Those are huge acquisitions, high dollar amount. There are a lot of acquisitions that go under the radar and if you are capital efficient with all of this and you can prove really good clinical data.

Duane Mancini [00:32:36]:
There was just one up in Michigan where Stryker acquired Amplitude Vascular. It's a pre commercial company that achieved really good clinical data. And Stryker came in and said, Perfect, here's $400 million. We're going to put this into our sales system and sell this product because you spent time really figuring out where those painful bumps are going to be in this clinical validation and that's even a big one. There's other ones that happen all the time where people raise 5, $10 million and exit for a hundred and that's a really good multiple for those early stage investors. But that clinical piece is the biggest de risking piece that you can do as an early stage startup. And don't rush through it just to get to revenue. Take your time, really figure it out.

Duane Mancini [00:33:26]:
The first product you go to market with is probably not the one that you're going to go commercial with. In some cases it is, but in a lot of cases it's not. You're going to make some adjustments and then you're going to commercialize that.

Jeffrey Stern [00:33:38]:
So when a founder comes to you and, and says we need to raise capital, what generally how do you triage in the sequencing of, you know, regulatory, clinical reimbursement, commercial. What, what is, how does capital play in the life cycle of life sciences businesses relative to again kind of the software or CPG kind of world? That, that is different because I, I do think it is different and I think it's interesting just to unpack the, the nuance of it.

Duane Mancini [00:34:10]:
Yeah, yeah. I think when you, when you think about, you know, how the capital plays in, there's obviously a lot of non dilutive opportunities as well and you gotta, you have to play that up as much as possible. Ohio actually is a tremendous state from a non dilutive perspective and there's a lot of really good resources that folks can use in order to de risk your business. The big, the big, the first thing we have to educate them on is the milestones that you think are a, are big milestones are probably not big milestones for investors, right? Like at an early stage, especially when they first come to us and start talking about, hey, let's go raise from investors. It's. Well, hold on a second. We need to have a succinct story here, right? And the first thing we need to figure out is the first question we're going to get, no matter what, is what's the regulatory path with, with the fda? So let's, let's get that figured out first. Let's, let's talk about that.

Duane Mancini [00:35:09]:
But before we talk about that, let's talk about what your economic value is to the health system. So we have to answer those questions first. And if we can't answer, we can always answer what the value is for the patients or the clinicians for sure. But we have to address regulatory and economic value to payers and providers. Once we can address that, then we can go to investors and talk to them about, hey, the core thing that you have to convince them of is they have to see a path to get a return. There's not many investors out there who are just throwing money, you know, and not expecting a return on this. So we have to be able to show them that there is a return that can come to them and there's a very realistic path to that. And then, you know, so, so once we can get through all that, then it's talking to them about a little bit more about the strategy of who we're going to go to, the fact that we have to have flexibility because if you raised money once, you've raised money once, right.

Duane Mancini [00:36:07]:
There's a lot of different ways to, to, to get to the desired outcomes you need. And so we have to talk to them about the FL of that and being able to make in game adjustments, if you will. Right. To, to finish these rounds out. But where do you go for them? You know, that's, that's the other piece that the podcast has been super valuable for us is we've developed a list of probably 230 life science investors all over the US and, and, and mostly Europe, but a little bit in Israel as well. And it's just like there's, there's a lot of capital. You just gotta find it, match it up, figure out what stage you're at. The other thing to be careful about is who are you talking to? Don't go talk to a late stage investor and ask them what they want to see because they're going to tell you that they probably want to see revenue or they want to see clinical traction.

Duane Mancini [00:36:58]:
And then all of a sudden you have an entrepreneur now focused on, well, I got to get to revenue. Because so and so said that they'll invest if they have revenue. And it's like, well, you're five years from revenue. They might not even have a fund by then, they'll probably be fully invested and then maybe their fund thesis has changed, you know, so there's a lot of education that has to happen, Jeffrey, at the beginning, right. Of what do you need? But then also the different types of investors. VCs, early VCs, angel groups, corporate venture, hospital venture, family offices. What do they all want to see? How rapidly do they change and what motivates them? So kind of giving them that lay it a land, if you will, is really beneficial.

Jeffrey Stern [00:37:43]:
Yeah. In my experience navigating healthcare and building solutions for it, I've come to understand that a lot of the justification for the way things are done is frustratingly often that's just the way they've always done it. And that's the reason why. Which is, you know, I think not. When that's the answer to why you do things the way you do, it's like an indication there's a lot of opportunity to maybe rethink how that works. Having seen as many companies as you have navigate this journey, what are the parts of the ecosystem and the process of getting something to market that you feel is most frustrating, like an alternative way of asking if you could redesign the process from scratch and address the justification for the way things are as the way things have been done, what would you want to change?

Duane Mancini [00:38:35]:
Mm, yeah, it's a good question. It's so funny because I think I'd have more answers for this if it wasn't for the podcast. Because I've things I've thought I've heard opposing views for, you know. Yeah, yeah. And it's changed. It's made me less confident in some of the answers. I think if I could change one thing, it would be that sometimes I think earlier stage investors think they have a hard. They have a hard job, but I think they think that they can pick winners and losers much earlier than I think is actually realistic.

Duane Mancini [00:39:18]:
Because the dynamic and aspect I think is really hard to figure out at that early stage. Like we just. I know what I'll change because it's got me thinking about it is that there's always this. Sometimes I talk to these low ecosystem folks within local ecosystems and their, their, their first complaint is, well, we don't have enough jockeys for horses. And I think that is bs. I really don't think that is a, a, a bottleneck. There are so many, especially in, in life sciences. There are a lot of opportunities that does not require someone who's been there, done that to spin it out of a institution and get it at least to the point where maybe you can bring in a CEO.

Duane Mancini [00:40:08]:
I do think that is a, I don't agree with that. I think there's enough entrepreneurs that, or willing entrepreneurs with the help of services like Project MedTech and others to get them far enough to where you can make a better decision on whether that person can actually take it to the next step or need to pass it along to another CEO. But at least it's de, risked a little bit. I just, I don't know too, too many things I think sit within local ecosystems. I'm not, I'm not talking about Cleveland. I'm talking about just local ecosystems in general where there's this, yeah, you know, hey, we don't have enough jockeys to take these. And it's like, I, I don't buy that the, the, the product is not baked enough to, to make that decision. Spin it out, let it go.

Duane Mancini [00:40:59]:
Let a first time entrepreneur take it. Or I mean, what, what's, what's the alternative? It sits in the institution and never sees a patient? I don't know. Yeah, I, I, I think that would be my biggest thing I would rewrite is get that out of your head. That doesn't need to be the case.

Jeffrey Stern [00:41:15]:
Hmm. Sort of. What do you wish more people understood about this space that maybe they don't?

Duane Mancini [00:41:24]:
That your pathway with the FDA should not be web, should not be the decision on whether you invest or not. There is, we hear this so many times where investors like, ooh, it's, you know, with, with medical devices, there's a few different pathways with the FDA and they change the, the, they go based off risk. Right. So you know, class one medical devices, you have class two and you have class three. Class one is a medical device that if it fails, it poses very little risk to the patient. Class three is like a pacemaker. Right. If that pacemaker fails, a patient can die.

Duane Mancini [00:42:00]:
Right. That's a, that's a high risk. There's different pathways through the FDA. There's, there's ones that are what, what's called a 510K. There's ones that are called a de novo and a pma. De novo. And PMA being longer, maybe requiring more data to kind of get clearance. We hear so many investors say they're, they're a 510k.

Duane Mancini [00:42:20]:
So this is really good. It's going to be easier to get through the fda. And again, I'll go back and talk about the fda. The FDA does not buy your medical device. And I think that's a really broken way of thinking. You're going to need clinical data in order to achieve market access and achieve to get to an exit. You're going to need these things. So just because the FDA tells you that you don't need clinical data, that shouldn't be a reason why you invest or not.

Duane Mancini [00:42:53]:
And so I would, I would break. Yeah. If I could, if I could educate investors coming into the space, it would be that. That shouldn't be the first question you ask. That should be a, a secondary question, not a whether you invest or not question.

Jeffrey Stern [00:43:10]:
What should be the first question?

Duane Mancini [00:43:12]:
What is the economic impact you're providing to the US Healthcare system? I mean that's the first thing you need to understand. Whether we like it or not, healthcare is a business. And there are two primary economic decision makers in the US healthcare system. And you need to understand the motives behind each one of those. You have insurance companies and payers and then you have the providers, the US healthcare systems, whether they're the hospitals, the surgical centers, whatever it is. And so at a core you have to be able to answer what's the economic impact that you're going to provide to these different groups? And so that should be the first thing you're thinking about is if you don't have a slam dunk, we are doing this for one of these, these groups, then are you cheaper than the competitor? But you have to answer, we're talking about a business. So you have to answer the economic impact. That should be the first thing that anyone should want to understand about an early stage opportunity is how do you thought through that and what is the economic impact?

Jeffrey Stern [00:44:18]:
How do you think about your, your own kind of impact with regards to, you know, driving results for other companies? Like how do you measure your own success? What is the kind of impact that you would like to have? Looking back in retrospect?

Duane Mancini [00:44:32]:
Yeah, it's, it's, that has been in stages. Right. So that's an easier question to answer in terms of where we're at in the staircase. At first it was can we help some really early stage companies raise capital and get to the next step?

Jeffrey Stern [00:44:47]:
Yeah.

Duane Mancini [00:44:47]:
And we've 100% answered that in 2024. There was a point in time where we had like what we call enterprise companies, which are companies using us to help in more than just one of our domain expertise, where maybe we're helping in finance reg and commercial. And out of the 32, 24 had raised capital in like a six month period. Like that was a very good validation point for us of, okay, cool, that means we're getting companies to the next step. Then the next milestone after that was are we getting companies we're working with from idea to in the clinic? That's a big milestone for us. Right. So, so when we talk about how measuring our impact, I mean our, our mission is to accelerate medical technology to improve patient lives. And our vision is to create an ecosystem where medtech companies can thrive in.

Duane Mancini [00:45:43]:
And so I think when you take those two things and you measure well, what, what's measurable there it's are companies raising capital and getting to the next step. Are companies reaching patients and getting into the clinic, Are companies successfully commercializing and then are companies getting to exits? And so, you know, if we think about the timeline, most medtech companies, the exit time is like nine to 10 years. Well, Project MedTech's been around since 2020 and we've had a consulting division since 2022. So what can we realistically measure ourselves on? We were able to measure ourselves on, on companies getting funding, that's for sure. We're now able to say companies are getting into patients and our next one will be are companies getting to exits? Now we've had two companies get to exits, but I think, you know, those are probably just those, those, those are outliers. But now that more companies are progressing, how many are going to get to that, that exit point, you know, three, four, five years from now? So those are our big ways we would probably measure our impact. And it's more than just consulting companies who have come to events and pitched at events or been on the podcast. It's like watching those companies be successful.

Duane Mancini [00:46:56]:
Have we, have we played even a small role in that? Obviously with consulting there's a heavier hand and our role there, but for us it's all about impact. Like, even when I was at, even when I was at namsa, I used to geek out on the fact that even if I just did their biological safety testing, which is a checkbox, they got to do it and they were able to get to patients. I had a pretty, I felt pride in that. Like, it was like, hey, I worked on that product. And then you have those aha moments when you go see a family member in the hospital and you look at some of the different devices and you're like, I worked on that years ago. Like I did the safety testing or oh, we did the regulatory strategy on this or we did the regulatory submission and now it's affecting patients in a positive way. Those are the measurable moments for us, for sure.

Jeffrey Stern [00:47:44]:
Yeah. I mean, right. In the, the nature of the work you're doing, you don't need to make a big intellectual leap, you know, to understand. All right. This is helping people live their lives better. Yeah.

Duane Mancini [00:47:56]:
Longer, healthier lives.

Jeffrey Stern [00:47:57]:
Yeah. Yeah. It's easy to, to get behind. Yeah. Are you optimistic about the state of life sciences and medtech right now? What, what are, what are you most excited about? What, what kind of worries you?

Duane Mancini [00:48:11]:
Yeah, no, I. 100%. We're always bullish on, on that. I do think that when you compare the different parts of life sciences, like maybe pharmaceuticals to medical devices, to diagnostics, to, to digital health, I'm really bullish on the areas we focus in. We do, we do some small molecule work, but it does limit, like, we don't do anything on the regulatory side of that or the quality side. So it does limit a little bit of what we can do. But for medical devices, diagnostics and digital health, it's a Covid, like accelerated that forward because all of a sudden there was a focus on, you know, you, in this country, if you turn the TV on and watch it for two commercial breaks, you're probably going to see an ad for some pharmaceutical. Right.

Duane Mancini [00:49:01]:
You really don't see that much with device. You, you have in the past for some of these various glucose monitoring systems and maybe some of the insulin patches, but that's, that's fairly new. But the one thing that Covid kind of put a light on was your early detection systems, your diagnostic tests. Like, how do we identify whether we have this or not and how early can we identify it? And with medical devices, there's, there's, it's been pulled, pulled forward as well because there's a lot of innovation in there and it's a lot of, you know, people are a little more resistant for, to take a drug the rest of their life or maybe there's some type of permanent fix. Right. And so, and then I think on the digital health side and the wearable side, like, it empowers patients and individuals to take more control over their health. I mean, think about. I like, I just, I see it so much.

Duane Mancini [00:49:52]:
Like I wear, you know, I wear a garment, but I used to be a big whoop.

Jeffrey Stern [00:49:55]:
Yeah.

Duane Mancini [00:49:57]:
You know, until I, until I wanted to get into some endurance sports, so I needed the Garmin, but it's like a lot of people are wearing those things and, and being able to monitor their health. And so I, I think I'm just, I'm, I'm, I'm really bullish on the early detection system and people being able to intervene quicker because of various diagnostic tests and, and things we can do from that side, improvements and in imaging and a number of different areas like that. And so, yeah, I think that's a big piece and will carry a lot of them in for a lot of years.

Jeffrey Stern [00:50:36]:
I think you've alluded to this one kind of in pieces throughout the conversation. But what do you think the opportunity for Ohio is? What would you like to see happen there?

Duane Mancini [00:50:46]:
Yeah, I think Ohio has a lot of the really good ingredients and people are putting it together. People are not having to, to necessarily leave as well. And I don't think there's any reason to leave. Like, I think for me, the most important thing for an early stage life science company is that you're close to your customer base. I mean, if you just went down 71, why would you ever go? You don't have to go anywhere. You know, I mean, like I talked about Cleveland. You look at Columbus, you look at Cincinnati, right? There's top institution universities in all those areas. So there's enough research and innovation coming out of all the institutions, you know, within Ohio.

Duane Mancini [00:51:33]:
There's enough healthcare providers in Ohio with different patient populations all. And not just like rural to urban, but peds to adults. I mean, if you have a pediatric device, you really should come to Ohio. And there's a lot going on in that space. Investorized, right? There's more funds popping up, but there's also like, for us too, like, there's more funds popping up, but that's not even like a big issue for us. We have a lot of companies that are in Ohio who are raising capital, early stage seed capital from outside of Ohio. They're not moving to these other areas, but they're raising the capital and staying where they're at. So that's a positive thing.

Duane Mancini [00:52:16]:
And the more that happens, I promise you, the more early stage investors will say, hey, wait a minute, we weren't in on that deal. We want to be in on these deals. So they'll start looking at them more. And if these entrepreneurs have exits, they'll probably stay in Ohio and reinvest in Ohio. And then you have groups like yours and the Ohio Fund that are Solving really big issues because that's growth stage capital. So now these companies can grow here. And from an Ohio perspective, we do an event in Europe called Coming to America. It's obviously named after the Eddie Murphy movie.

Duane Mancini [00:52:50]:
And one of the first things we show is if you raised $2 million and you were a European company and you came to the US to set up your operations here to go after the US Market, if you lived in Ohio just off rent and talent, you would last twice as long as if you went to one of the coasts. And you know, one of the people said, well, yeah, but don't we want to be on the coast from a networking perspective? And I said, don't you want to be at the Cleveland Clinic or Nationwide Children's or Cincinnati Children's or University Hospitals? And it's like, oh, yeah, those are really good institutions. It's like, yeah, so no. Why do you want to be there? You know, you could set up shop here. So I think Ohio has a really interesting play. Also. We didn't even talk about manufacturing. So, like, when it comes to supply chain, it's like, Ohio does manufacturing really well.

Duane Mancini [00:53:43]:
So I think the core ingredients are here. It's just maybe not being one thing Ohio, the Midwest probably doesn't do well is talk about ourselves, sell ourselves. And I'm guilty of that too. Like, I mean, if anytime. And a lot of people are like this, like, anytime you talk about someone else in Ohio, it makes that person uncomfortable. You know, you're just trying to play them a conscience, but it makes them uncomfortable. You can see them squirm, you know, in their seat. And so I just think, you know, we gotta brag a little bit more.

Duane Mancini [00:54:15]:
We gotta talk about the wins. There's a lot going on, but Ohio has all the ingredients to do it, so. Yeah.

Jeffrey Stern [00:54:22]:
Yep. I certainly believe that as well. You, you mentioned some of the things we. We haven't talked about, and there's way more things that we haven't talked about then, then we have. Are there. Is there something that feels particularly important when you reflect on your journey, on the work you're doing? Anything else that you would want to kind of surface here?

Duane Mancini [00:54:44]:
Yeah, I think that the one thing that I think has been great is just the support, the people who get in your corner. Like when we first started, I think generally speaking there is a little bit of, of, hey, you know, can they actually do it? I know you're what you're talking about. Yes, that sounds great, but can you do it? But once you start to prove that out the ecosystem gets behind you for sure, which I think is a, A, a big benefit. And I know, like when, when we were expanding from working just with startups to now going a little bit earlier and working with more institutions, a lot of our initial support came from people in Ohio. Like, first big partnerships was with Bounce Innovation Hub and Jumpstart Case, Western Ohio State University of Cincinnati, like, nationwide Children's, the mpdc. Like, there's a lot of really good partners that believed in what we were doing and trusted us to add value to their organizations as well. And then that helps us. And, you know, now we've been able to expand that specific institutional support to areas all across the country.

Duane Mancini [00:56:04]:
But because we're able to do that with the institutions here and build that good partnership and almost have that clinical validation, but business validation and then have references like, I think that is a big piece of. This is with. Anytime you. You talk about local support systems, you know, it can be a mixed bag because some people are going to have bad experiences. But I think once we got past that hurdle of we're here to stay, we add value, the ecosystem is just really supportive.

Jeffrey Stern [00:56:36]:
Yeah, no, I certainly subscribe to the idea that if you, you put it out there, this is what you want to do, then the folks in your vicinity kind of conspire to help you get there.

Duane Mancini [00:56:48]:
Totally. Yep. If you, if you can, if you can create, put your head down and just focus on creating value, people will see it and then people will support you. And I do think Ohio has done that really well, at least for us. Right?

Jeffrey Stern [00:57:02]:
Yeah. Awesome. Well, we'll work to bookend it here. Yeah, Lots more I know we could talk about, but I'll hit you with our traditional closing question, which is for a hidden gem in Cleveland.

Duane Mancini [00:57:17]:
Ooh. Well, okay. I have to do this. And I have two. One, it's in Strongsville. There's a place called Don Pomeroy's House, and the restaurant's great. The pub is awesome. It's much more my scene.

Duane Mancini [00:57:31]:
They serve a really good pint of Guinness. It's. It's just a cool place. But that's nearby. But the place for Cleveland. Broader Cleveland. And his name is Justin Carolyn. Him and a group of others started a company called Martha on the Fly.

Duane Mancini [00:57:45]:
They do breakfast sandwiches. It's in Tremont. He's a friend from high school. It's awesome, though. It's. It's the best breakfast sandwich you'll have. They do lunch now as well. It's on Professor Avenue in Tremont.

Duane Mancini [00:57:57]:
It's a super small place. The place was designed by another friend of ours from high school. He did all the architectural work. It's a really cool place. And but the crazy story is Justin did the Project Medtech logo, so if this is on video shirt. Yeah, he, he designed the original logo for Project MedTech, but and also all the Martha on the Fly stuff. So Marth on the Fly, it's in Tremont. It's incredible.

Jeffrey Stern [00:58:25]:
It's a perfect plug. Well, Dwayne, I just want to thank you for coming on for the work that you do and sharing a bit of your story.

Duane Mancini [00:58:34]:
Yeah, thanks for having me on and thanks for the work you're doing too. Like I said, it's such a cool thing what you're doing and you're telling all these entrepreneurial stories and giving them a platform and you never know who you're going to connect with through these things. And so really appreciate all the work because I know it's a lot of hard work.

Jeffrey Stern [00:58:50]:
Thank you. It means a lot. Well, in the spirit of that, if folks had anything they wanted to connect with you, about to follow up, listen to your podcast or anything else, kind of where would you direct them?

Duane Mancini [00:59:03]:
Yeah, projectmedtech.com is a great place to start. It's actually going to be probably revamped by the time this gets released. ProjectMedTech on LinkedIn's a good spot. I'm pretty active on LinkedIn as well, so reaching out to me on LinkedIn and sending me a message, I'm always get back to people there. But yeah, those are are really good places to start.

Jeffrey Stern [00:59:20]:
Perfect. Thanks again Dwayne.

Duane Mancini [00:59:22]:
Awesome.

Jeffrey Stern [00:59:25]:
That's all for this week. Thank you for listening. We'd love to hear your thoughts on today's show, so if you have any feedback, please send over an email to jeffreyofthelandfm or find us on Twitter oddlehoftheland or Sternhefe. J E F E if you or someone you know would make a good guess for a our show, please reach out as well and let us know. And if you enjoy the podcast, please subscribe and leave a review on itunes or on your preferred podcast player. Your support goes a long way to help us spread the word and continue to bring the Cleveland founders and builders we love having on the show. We'll be back here next week at the same time to map more of the land. The Lay of the Land podcast was developed in collaboration with the UP Company LLC at the time of this recording.

Jeffrey Stern [01:00:09]:
Unless otherwise indicated, we do not own equity or other financial interests in the company which appear on this show. All opinions expressed by podcast participants are solely their own and do not reflect the opinions of any entity which employs us. This podcast is for informational purposes only and should not be relied upon as a basis for investment decisions. Thank you for listening and we'll talk to you next week.